Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144274
First received: September 2, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suf fering from acute viral pharyngitis. The primary endpoint is the time-weighted average of the pain intensity difference from pre-dose bas eline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline ( SPIDnorm).


Condition Intervention Phase
Pharyngitis
Drug: Ambroxol Lozenge
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Tolerability of Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis - A Randomised, Double-blind, Placebo-controlled Parallel Group Study. AMBROSIA: Ambroxol Lozenges In Sore Throat In Adolescents

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint is the time-weighted average of the pain intensity difference from pre-dose baseline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline (SPIDnorm).

Secondary Outcome Measures:
  • Pain intensity (PI) and pain intensity difference from pre-dose baseline Time to onset of action of lozenge Assessment of redness of pharyngeal mucosa at pre-dose baseline and end of study Efficacy and tolerability assessment Adverse events

Estimated Enrollment: 220
Study Start Date: April 2005
Estimated Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suf fering from acute viral pharyngitis. The pain intensity will be assessed by the patient on a 6-point rating scale before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter. The patient enters the rating in the patient's diary.

Study Hypothesis:

It will be tested whether a statistically significant difference exists in the S PIDnorm after the intake of the 1st lozenge between the group treated with ambro xol lozenges and the group treated with placebo lozenges.

Comparison(s):

Placebo comparison

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Patients having a sore throat with acute viral pharyngitis.
  2. Female and male patients from 12 and less than 18 years of age.
  3. The throat pain intensity is rated at least "moderate" on the VRS(PI).
  4. Written Informed Consent is given by the patient's parent/legal guardian, an d the patient is able to give Assent.
  5. Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary.
  6. Patient able to remain at the doctor's practice for the initial 3 hours follo wing the first intake of study medication, or known reliable patient, and able t o return for the study visits.

EXCLUSION CRITERIA

  1. Female patients who have begun menstruating and are:

    1. Pregnant
    2. Currently breastfeeding
    3. Of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implantable or injectable contraceptives. Abstinenc e can be used as contraception, at the discretion of the investigator.
  2. Patients with symptoms of primarily bacterial pharyngitis or bacterial secon dary infection (clinical findings inter alia assessment of exudate).
  3. First indication of symptoms of acute pharyngitis (e.g. sore throat) occurre d more than 3 days ago.
  4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
  5. Patient who in the past week, or during the study will require treatment with the following: antibiotics analgesics anti-inflammatory agents steroids fo r oral, inhaling or topical application expectorants or antitussives. No phys ical therapy (e.g. throat compress) may be applied during the trial.
  6. Patients with mouth breathing as a result of nasal congestion.
  7. Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge.
  8. Previous and/or existing tumour condition.
  9. Alcohol, and/or drug abuse.
  10. Any clinical condition which, in the opinion of the investigator would not a llow safe completion of the protocol and safe administration of trial medication.
  11. Any investigational therapy within 30 days prior to randomisation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144274

Locations
South Africa
Boehringer Ingelheim Investigational Site
Boksburg, South Africa, 1461
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7945
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7646
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7700
Boehringer Ingelheim Investigational Site
Durban, South Africa, 4091
Boehringer Ingelheim Investigational Site
Johannesburg, South Africa, 2033
Boehringer Ingelheim Investigational Site
Johannesburg, South Africa, 2192
Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa, 1739
Boehringer Ingelheim Investigational Site
Midrand, South Africa, 1685
Boehringer Ingelheim Investigational Site
Pretoria, South Africa, 0038
Boehringer Ingelheim Investigational Site
Pretoria, South Africa, 0157
Boehringer Ingelheim Investigational Site
Sandton, South Africa, 2021
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. South Africa (Pty.) Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00144274     History of Changes
Other Study ID Numbers: 18.487
Study First Received: September 2, 2005
Last Updated: October 28, 2013
Health Authority: South Africa: Medicines Control Council (MCC)

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ambroxol
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014